Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00806195 | Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants | PHASE3 | COMPLETED | 7,744 | — | — | Dec 1, 2008 | Nov 1, 2011 | Jul 9, 2013 | 153 | United States, China +4 |
To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM197 + Routine Vaccines (Non-Detailed) | EXPERIMENTAL | Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - infants who only provided SAEs (Serious Adverse Events) and medically attended AEs (Adverse Events). |
| Routine Vaccines (Non-Detailed) | ACTIVE_COMPARATOR | Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided SAEs and medically attended AEs. |
| MenACWY-CRM197 + Routine Vaccines (Detailed) | EXPERIMENTAL | Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs. |
| Routine Vaccines (Detailed) | ACTIVE_COMPARATOR | Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs. |
| MenACWY-CRM197 + Routine Vaccines (All) | EXPERIMENTAL | Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs. |
| Routine Vaccines (All) | ACTIVE_COMPARATOR | Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs. |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM197 | BIOLOGICAL | Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age. |
| DTaP (Diptheria, Tetanus, Pertussis) Vaccine | BIOLOGICAL | Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age. |
| Hib (Haemophilus influenza b) Vaccine | BIOLOGICAL | Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age. |
| IPV (Inactivated Polio Vaccine) Vaccine | BIOLOGICAL | Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age. |
| Pneumococcal conjugate Vaccine | BIOLOGICAL | Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age. |
| MMR (Measles, Mumps, and Rubella) Vaccine | BIOLOGICAL | One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age. |
| Varicella Vaccine | BIOLOGICAL | One vaccination of Varicella vaccine was administered at 12 months of age. |
| Hepatitis A Virus | BIOLOGICAL | One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age. |
Inclusion Criteria: * healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg * for whom a parent/legal representative has given written informed consent after the nature of the stud...